Clinical Trials Directory

Trials / Completed

CompletedNCT00117559

Improving Quality of Life for Veterans Undergoing Interferon Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
US Department of Veterans Affairs · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.

Detailed description

The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus (HCV). The specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. Participants will be 45 patients (15 participants in each condition) from the VA Boston Healthcare System who are undergoing interferon treatment for HCV. Assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. Assessments will measure key areas, including adherence, quality of life, and psychological distress. Analyses will examine study feasibility and the effects of the treatment condition. It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTelehealth TreatmentParticipants receive a 15-minute telephone call for 8 weeks

Timeline

Start date
2005-07-01
Primary completion
2008-06-01
Completion
2008-06-01
First posted
2005-07-07
Last updated
2014-12-11
Results posted
2014-12-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00117559. Inclusion in this directory is not an endorsement.